Numerous medical and surgical procedures require catheterization. The catheters utilized for such procedures must be rapidly clamped upon insertion so that they are held in a predetermined fixed position and must therefor be easily adjusted. Numerous types of catheter holders have been proposed by those skilled in the art. Presently, the varieties of catheter holders range from the use of the simple expedient of adhesive tape wrapped around a patient's limb and over a catheter tube to more sophisticated mechanical devices.
Tape arrangements have obvious drawbacks in that they are irritating to the skin of the patient, time consuming to apply and remove, and do not always secure the catheter. Adhesive tapes often fail to prevent a catheter from rotating. The adhesive portion of the tape may also cause a physical-chemical degradation of the catheter tube. Further, tapes are easily contaminated by micro organisms, etc. and cannot be easily cleaned.
Prior art mechanical catheter clamps have typically been cumbersome and have often included complex mechanical parts which may impede the flow of fluids through the retained or clamped catheter. Many prior art catheter clamps deform the catheters with which they are used and often utilize complex attachment means. Such catheter clamps are difficult to quickly move and maneuver. Further, a number of prior art clamps rely upon adhesives for purposes of securing the catheter to the patient. Such adhesives tend to lose their gripping ability after the catheter is turned or twisted, and often have the above discussed problems associated with adhesive tapes.
A number of patents have highlighted the types of problems associated with prior art mechanical catheter clamps. U.S. Pat. No. 4,360,025 discloses a catheter clamp constructed from a plastic material having a central hole which is fully or partly defined by a pair of resilient catheter-gripping serrated jaws and a resilient catch member for holding the jaws in their relatively closed position. The serrated jaws of this clamp may have a tendency to dig into or deform the catheter. Further, the arrangement requires that the catheter enter the body substantially perpendicularly to the skin surface.
U.S. Pat. No. 4,699,616 discloses a device for retaining a drainage catheter in place at its point of entry into a patient's body at an attitude which is perpendicular to the skin surface. The device includes a resilient, adhesive barrier pad having an opening intended to be aligned with the fenestration in the body wall. The pad has an entry slit leading to the opening. In use, the catheter is guided laterally through the entry slit to the opening of the barrier pad and then supported by mechanical support arms which may deform the catheter. The resilient pad is then adhesively secured to the patient with the edges of the pad defining a slit urged tightly together.
U.S. Pat. No. 3,487,837 discloses a mechanism for retaining a catheter in position such that the catheter is frictionally gripped by the taper in a bell shaped elastic body. The elastic body has a narrow neck for forming a walled sleeve about the catheter, and the cavity is formed in the wall inwardly of the sleeve. Any tendency of the catheter to move outward causes the sleeve to stretch and resist this movement.
U.S. Pat. No. 4,170,995 discloses a holder for clamping a catheter or other hollow tube. The holder comprises a pliant adhesive base which is adhered to the patient's skin. The holder is adjustable so as to be securer against rotary and longitudinal movement. The device also incorporates a screw and nut configuration which is comparatively difficult to quickly affix and adjust. The device deforms the catheter in use and is adjustable to completely cut off flow.
U.S. Pat. No. 4,702,736 discloses a clamp for holding an article such as a catheter. The device includes a series of folding flaps comprising resilient adhesive surfaces. These surfaces adhere the catheter to the base of the clamp.
Finally, U.S. Pat. No. 4,842,592 discloses an adaptive connector assembly for engaging a catheter. The invention comprises a pair of segments adapted for telescoping engagement so as to provide a central cavity for receiving a plug of compressible material. One of the segments has an opening which communicates with the cavity and is adapted to receive the catheter. The plug has a centrally disposed channel for receiving the catheter from the opening. A snap-fit engagement is developed between the telescoping segments so that when the telescoping segments are engaged, the plug is placed in compression, constricting the channel about the catheter and thereby engaging the catheter within the adaptive connector assembly. This device is comparatively complex and includes a number of parts, including a separate plug which must be properly positioned for use.
There have also been a number of prior art patents directed to adaptors for connecting a catheter to a syringe. None of these devices discloses or suggests the catheter clamp of the present invention. U.S. Pat. No. 3,752,510 discloses a connector structure for connecting a flexible tube to a syringe having a luer tip. The patent utilizes a construction in which a retainer and tube end are urged into a tapered bore.
U.S. Pat. No. 4,834,719 discloses a quick connect/disconnect tubing adapter with locking mechanism for capturing a tube within the adapter. The adapter comprises two mating body portions having passageways for receiving a tubing end portion. Each of the above methods and devices for clamping a catheter is cumbersome, and makes the catheter difficult to attach quickly and to easily decouple. It is often important to rapidly affix and adjust a catheter into position. This is particularly difficult with clamps such as disclosed in U.S. Pat. No. 4,360,025. In addition, clamps incorporating the use of adhesives, such as disclosed in U.S. Pat. No. 4,170,995, do not always adequately secure the catheter and present the previously discussed problems associated with adhesives.
It would be desirable to have a device for clamping a catheter which can be quickly clamped and unclamped. It would be particularly desirable to have a catheter clamp which can be easily clamped and unclamped with a single twisting movement. Such a clamping device could be quickly attached to a catheter without the need for adhesives.
It is accordingly an object of the present invention to provide a non-rotational catheter clamp which can be rapidly attached and released for repeated use.
It is still a further object of the present invention to provide a snap acting non-rotational catheter clamp which can be rapidly and easily attached and decoupled by a single twisting movement.
It is still yet a further object of the present invention to provide a snap acting catheter clamp which can be attached and adjusted without deforming the catheter with which it is utilized and without the need for adhesives.
It is an additional object of the present invention to provide a catheter clamp which can secure catheters having a variety of diameters.
It is a further object of the present invention to provide a catheter clamp which could be utilized for controlling the adjustment of a catheter such as disclosed in U.S. Pat. No. 4,327,723. The inclusion of the clamp of the present invention is uniquely suited for connection to the protective sheath of a shielded catheter such as disclosed in Patent 4,327,732 in that it allows for periodic readjustment and clamping of the catheter in a readjusted position without risk of catheter sepsis.
These and other objects of the present invention will become apparent from the Summary and Detailed Description which follow.